From breakthrough to bedside - Your specialists for personalized medicine
Advanced Therapy Medicinal Products are redefining what modern medicine can achieve, offering new possibilities for patients with serious and often previously untreatable diseases. However, the development of cell therapies, gene therapies, and tissue-engineered products requires careful coordination across highly specialized manufacturing, logistics, regulatory, and clinical processes. FGK brings extensive experience in supporting ATMP programs, navigating the unique operational and scientific requirements that accompany these innovative therapies. From first-in-human studies to later-stage development, we help ensure that groundbreaking concepts are translated into clinical programs capable of delivering meaningful results for patients and stakeholders alike.
Our core competencies in ATMP studies:
- Coordination of complex clinical studies
- Regulatory handling in different countries
- Management of traceability
- Addressing of ATMP-specific requirements (e.g. Control of donor etc.)
We have performed international first-in-man and first-in-patient studies.
Our clinical trial experience spans:
- Venous ulcer
- Diabetic neuropathic ulcer
- Ophthalmology
- Balloons (also drug coated)
- Heart failure
- Haemophilia
- Limbal stem cell deficiency
- Peripheral arterial occlusive disease
- Epidermolysis bullosa
- Acute-on-chronic liver failure
- Adenocarcinoma
Prof. Michael Hudecek, University Hospital Wuerzburg
Chair of Cellular Immunotherapy
Since 2018, FGK has been an invaluable partner in our clinical early-phase CAR-T cell projects. Their extensive experience in advanced new therapies, like ATMP and cell therapy projects, has provided us with the expertise and support needed to navigate this complex field. Their commitment to high-quality research and their deep understanding of innovative therapies make them a trusted and essential partner in our development efforts. We look forward to continuing this successful collaboration.
Christoph Ganss, Rheacell
Founder & CEO
We have been collaborating with FGK for many years, and their professionalism, flexibility, and deep expertise in clinical trials have consistently exceeded our expectations. Their team’s ability to adapt quickly while maintaining the highest quality standards has been instrumental in the success of our Phase I/IIa and Phase IIb studies across multiple indications. The involvement of the upper management in all kinds of discussions is highly appreciated, again during our ongoing Phase III trial. We highly value this partnership and look forward to continuing our successful collaboration.
Ready to advance the next generation of therapies? Let’s talk about your next ATMP study. Get in touch with us.
